EPA Assistant Administrator Declares Intent to Apply TSCA Regulations to Articles
Signaling the position EPA is likely to assert when it finalizes a proposed rule that would impose extensive reporting requirements for producers and importers of products containing PFAS, on September 28, EPA Assistant Administrator Michal Freedhoff sent the clearest signal yet that importers of manufactured goods and finished products, including consumer products, will increasingly face compliance obligations under the Toxic Substances Control Act (TSCA). In remarks to the Product Stewardship Society, she said that chemical substances in such goods and products—“articles,” in TSCA parlance—are subject to TSCA, and that importers of articles containing chemicals can be regulated as “manufacturers” of those chemicals.
EPA has previously interpreted TSCA as authorizing the regulation of articles, but only on rare (and comparatively recent) occasions has the Agency exercised this authority. But it is apparent that under the leadership of the Biden team at EPA, the Agency is shifting to a TSCA policy framework in which regulation of articles is the rule and not the exception. This shift affects both ongoing and future activities and likely will require heightened scrutiny of global supply chains. Perhaps most important to note is the recently-closed comment period for a proposed rule requiring retrospective reporting on the manufacture of perfluoroalkyl or polyfluoroalkyl substances (PFAS) since 2011. The proposed rule included articles containing PFAS within its scope. If promulgated without changes, all importers of manufactured goods and finished products would have to investigate whether products imported over the last 10 years, or their individual components, contained PFAS—likely a daunting task for many businesses.
This is especially noteworthy, because since Congress originally enacted TSCA in 1976, EPA has never required the importers of articles to provide any documentation concerning the compliance status of such articles under the import certification requirements imposed by Section 13 of TSCA. How the changes EPA is signaling will align with, or potentially disrupt, the ordinary course followed with the US Customs Service and Agency procedures for shipments of imported articles remains to be seen.
EPA’s shift in policy for articles eventually could affect EPA’s implementation of the TSCA new chemicals program (under TSCA Section 5) and could potentially change how EPA is approaching the development of new risk management rules (under TSCA Section 6).
It is notable, however, that the 2016 amendments to TSCA added provisions that pertain specifically to how articles can be regulated in the Agency’s new and existing chemicals programs. For the new chemical program, Section 5(a)(5) provides that EPA can require significant new use notification “for the import or processing of a chemical substance as part of an article or category of articles … if the Administrator makes an affirmative finding … that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule justifies notification.” For the existing chemicals program, Section 6(c)(2)(E) provides that risk management rules shall apply prohibitions and other restrictions to articles “only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment.”
These statutory provisions may constrain EPA’s ability to implement an “across the board” the shift in TSCA policies that Assistant Administrator Freedhoff’s remarks signaled. It appears Dr. Freedhoff’s remarks could have broad implications and will most likely pertain when EPA contemplates the pending PFAS rule, and future reporting rules, under TSCA Section 8 (which contains no article-specific provisions). Certainly, the countless entities in the US, including international retailers, that act as importers of consumer goods as well as complex industrial, commercial, and even military equipment, will need to follow these TSCA developments closely to ensure they know about, and understand any new obligations.
© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.